Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020989
Company: DAIICHI SANKYO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVOXAC CEVIMELINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/11/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20989lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20989ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-989_Evoxac.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/08/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020989s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020989s008ltr.pdf
12/13/2005 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020989s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020989s006ltr.pdf
01/04/2002 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/2001 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/2000 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020989s008lbl.pdf
12/13/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020989s006lbl.pdf
01/11/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20989lbl.pdf

EVOXAC

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 091260 APOTEX INC
CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 204746 NOVEL LABS INC
CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 203775 RISING PHARMS INC
CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription No AB 091591 WEST-WARD PHARMS INT
EVOXAC CEVIMELINE HYDROCHLORIDE 30MG CAPSULE;ORAL Prescription Yes AB 020989 DAIICHI SANKYO INC

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